The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.
Objective: The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo or Artemis Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study. Study Design: This study will be a prospective, multi-centered trial that will enroll 50 patients at up to 10 United States (US) centers. Patient Population: Patients with moderate-large volume (20-80 cc) supratentorial intracerebral hemorrhage (ICH) who present within 24 hours of symptom onset. Enrolled patients will receive minimally invasive endoscopic evacuation with the Apollo system or Artemis Device. Indication: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system or cerebrum. In the present study, the researchers propose to investigate the feasibility of studying this patient population for eventual implementation of efficacy trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.
Subjects will receive best medical management for intracranial hemorrhage
George Washington University
Washington D.C., District of Columbia, United States
University of Louisville
Louisville, Kentucky, United States
University of Buffalo
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of Participants Enrolled Within 730 Days of First Enrollment
Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment
Time frame: 730 days
Number of Participants With Available mRS Score
Rate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days
Time frame: 180 days
Stroke Impact Scale - Mobility
For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale: * 1 = could not do it at all * 2 = very difficult * 3 = somewhat difficult * 4 = a little difficult * 5 = not difficult at all Stroke Impact Scale full scale from 0-45, with higher score indicating better health outcomes
Time frame: 180 days
Stroke Impact Scale - ADLs
For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale: * 1 = could not do it at all * 2 = very difficult * 3 = somewhat difficult * 4 = a little difficult * 5 = not difficult at all Stroke Impact Scale - ADL's full scale from 0-50, with higher score indicating better health outcomes.
Time frame: 180 days
EQ-5D-5L
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, may be converted into a single index value. scored as 1 = no problem to 5 = severe problem Full scale from 0-25, with higher score indicating better health outcomes.
Time frame: 180 days
Length of Hospital Stay
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Geisinger Medical Center
Danville, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
University of Washington
Seattle, Washington, United States
number of days of hospital stay
Time frame: average of 14 days
Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3
Number of participants with modified Rankin score (mRS) less than or equal to 3 to assess global disability assessed. The Modified Rankin Scale (mRS) The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: 180 days
Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume
Predominantly or Only ICH: Number of participants who meet both criteria of reduction of reduction to \< 15 cc total volume AND \>60% reduction in hemorrhage volume on immediate post-treatment CT scan. Number of participants who meet both criteria of reduction of Hemorrhage volume as indication of surgical success.
Time frame: 180 days
Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5
Predominantly or Only IVH: number of participants with IVH (mGraeb \> 0) with an mGraeb score of less than or equal to 5 on day 7 CT scan. Number of participants with IVH (mGraeb \> 0) with an mGraeb score of less than or equal to 5 as indication of surgical success.
Time frame: Day 7
Number of Participants Who Died Within 90 Days of the Procedure
Rate of mortality as Safety Endpoint. Number of participants who died within 90 days of the procedure.
Time frame: 90 days